American Heart Journal
Volume 151, Issue 3 , Pages 633-642, March 2006

Clinical trial issues in weight-loss therapy

  • Manesh R. Patel, MD

      Affiliations

    • Duke University Medical Center, Durham, NC
    • Corresponding Author InformationReprint requests: Manesh R Patel, MD, 111 VA Medical Center, Box 31152 DUMC, Durham, NC 27708.
    • ,
  • Mark Donahue, MD

      Affiliations

    • Duke University Medical Center, Durham, NC
    • ,
  • Peter W.F. Wilson, MD

      Affiliations

    • Medical University of South Carolina, Charleston, SC
    • ,
  • Robert M. Califf, MD

      Affiliations

    • Duke University Medical Center, Durham, NC

Received 8 March 2005; accepted 8 March 2005.

Background

Overweight and obesity rates continue to increase nationally, generating significant interest in weight-loss therapies to address both the burden of obesity-associated chronic disease and individual concerns about appearance. Effective obesity therapies also have the potential for off-label use and unintended consequences.

Methods

The behavioral, pharmacologic, and surgical therapies for obesity are reviewed. Clinical trial issues common to chronic disease states and issues specific to obesity trials are examined. Finally, study designs for obesity therapy, including populations, control arms, sample size, and duration of therapy, are discussed.

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PII: S0002-8703(05)00252-8

doi:10.1016/j.ahj.2005.03.006

American Heart Journal
Volume 151, Issue 3 , Pages 633-642, March 2006

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